Colorcon's brand enhancement services team (BEST) will be commercialising the new system, which incorporates one of DataLase's well-known laser-based marking techniques, Pharmamark. Pharmamark, patented by DataLase, is an edible, on-tablet marking system that can be used to record information such as barcodes, logos, patient details, dosage information or use-by dates all through a non-contact laser-based marking system. Certain additives are incorporated into the standard tablet coating, and a computer controlled low-power laser beam then etches the required data onto the designated area on the tablet surface. The area undergoes a colour change when struck by the laser light, forming the desired image or data on the tablet surface. Colorcon has licensed certain patented DataLase additives to incorporate into film coatings for pharmaceutical or nutritional supplement tablets, so that the colour change that appears when the DataLase-approved CO2 laser strikes occurs in the film coating itself. According to Colorcon, this is the very first time that film-coated tablets will be able to be marked using an advanced non-contact process. The technique will offer manufacturers an alternative to the use of printing inks or debossing tablets to identify their products. It also eliminates the risk of cracked or damaged tablets as a result of contact marking systems, undesired ink spots affecting machine readability, and the time pressure associated with waiting for ink to dry. Using the laser inscription system could also result in the removal of the need for some solvents during manufacture, a cleaner operation, fast change-over of product lines and potential cost-savings, according to Colorcon. The Pharmamark additives are excipients that meet all the compendial and regulatory requirements for use in the US and key European countries, and have been in use in approved pharmaceutical products for a number of years, says DataLase. A US drug master file (DMF) is due to be submitted which will detail all the relevant additive and laser technology information required for review by the US Food and Drug Administration (FDA) during the drug registration process. Colorcon and DataLase plan to schedule a meeting with the FDA to discuss the joint project and any queries the agency may have. The license agreement adds another arrow to Coloron's quiver of technologies for tablet identification, and provides a brand new option for manufacturers of film-coated tablets to protect their products. In the fight against the growing scourge of counterfeit activity in the pharma industry, an identification and authentication system that goes right down to the individual tablet level could be a significant weapon, protecting the dosage form itself rather than relying solely on packaging-based anti-counterfeit measures.
